Quality of evidence in pharmacovigilance

Database WITHDRAWN lists 578 drugs that were pulled out of global markets due to safety reasons. Most importantly, the database contains information about therapeutic targets, off-targets, underlying mechanisms of toxicity involved, and biological pathways. In addition, the database maps single nucleotide polymorphism (SNPs), genetic variations that are associated with toxicity in some people [1]. Post-market safety withdrawals occur for a variety of reasons, from lack of efficacy to manufacturing and business reasons. Yet, for approximately half of the drugs in

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The right drug at the right dose to the right patient: the value of pharmacogenomic information

In April 2019, Mozilla internet health report published an article “23 reasons not to reveal your DNA” [1]. The primary reasons why people should worry about sharing their DNA with strangers are quite obvious – privacy concerns, the potential for abuse and limited validity of the findings top the report’s list of reasons. While there are good motives why one should stay away from universal wavers that allow the use of DNA for research by third parties, such judgment is

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Social media as a source of adverse drug effects

People increasingly turn to online sources to search for health-related information, investigate options they have, and only then decide whether it is worth investing time and money to get the qualified opinion of a healthcare professional. Pew Research Center asked U.S. adults about their behavior online when it comes to health-related questions. The results were astonishing: 35% of U.S. adults went online to figure out a medical condition they or people around them might have. Of these online diagnosers, 46%

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Digital epidemiology in pharmacovigilance

One of the most important shortcomings of the current pharmacovigilance data collection system is the fact that the FDA Adverse Drug Event Reporting System (FAERS) does not provide any insight into the incidence, prevalence, and rates of occurrence of adverse drug events in the post-approval period [1]. To improve the ability to detect trends and rates, data collection systems need to be modified to incorporate less traditional data points. The utilization of patient-generated data such as search engine logs, social

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Pharmacovigilance at a crossroads

The global pharmacovigilance market is growing and is still expected to grow. In 2013, post-market safety surveillance accounted for 60% of the global pharmacovigilance market and should reach $6 billion by 2020. Main drivers for increased reporting of adverse drug reactions include compliance requirements and liability resulting from high-profile product failures. Implementation of a reporting system to comply with regulatory requirements for a Phase I study can cost about $100,000, before the first serious adverse event (SAE) even occurs [1].

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The compliance trap

Pharmaceutical industry is a tightly regulated business, especially in the U.S. and in Europe. Before medicines reach the market, they must undergo extensive clinical testing. Upon reaching the market, approved drugs can be prescribed to any patient if the physician can reasonably expect therapeutic benefit for the specific patient. Clinical research on human subjects can be sponsored by the industry, academic institutions, hospitals and even by individuals. A sponsor is the organization or person who initiates the study and who

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The cost of patient harm

U.S. health care spending reached $3.5 trillion in 2017, of which hospital care was $1.1 trillion and physician and clinical services was $694 billion. Retail prescription drugs cost $333.4 billion [1]. The cost of drug-related patient injury, referred to adverse drug events (ADEs) in the U.S. is estimated at $528 billion in 2016 [2]. Costs associated with ADEs include new hospital admissions, readmissions, prolonged length of inpatient stay and additional therapeutic interventions. According to a decade old research published by

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Pharmacovigilance history, importance and current status

Pharmacovigilance, a science that studies the adverse effects of medicines, has come a long way since its inception in the 1960’s when the thalidomide disaster occurred. Manufacturers of medicinal products must prove the safety and efficacy of their products to obtain regulatory approval and place their product on the market. Side effects of medicines identified in clinical trials are now included in the drug label, along with indications, contraindications, interactions with other drugs and conditions of use. Specific population subgroups

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